CLEARBLUE EASY EARLY RESULT PREGNANCY TEST

K013372 · Unipath , Ltd. · LCX · Nov 9, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013372
• Device Name: CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Nov 9, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mlU/ml hCG in urine, and is indicated for use from four days before the expected missed period.

Device Story

Clearblue Easy Early Result Pregnancy Test is an over-the-counter, lateral flow immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine. Device detects pregnancy by identifying hCG hormone levels at a sensitivity of 50 mIU/mL. Intended for home use by consumers; provides visual results indicating presence or absence of pregnancy. Early detection capability allows testing up to four days before expected missed period. Results assist users in early pregnancy confirmation.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on technological characteristics and performance specifications for hCG detection.

Technological Characteristics

Lateral flow immunoassay; detects hCG in urine; sensitivity 50 mIU/mL; over-the-counter diagnostic test format.

Indications for Use

Indicated for the detection of pregnancy in women using urine samples. Suitable for over-the-counter use starting four days before the expected missed period.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 0 9 2001

Mr. Steven H. Armstrong Assistant General Counsel-Marketing Unilever United States, Inc. Lever House - 390 Park Avenue New York, NY 10022-4698

Re: k013372

> Trade/Device Name: Clear Blue Easy Early Result Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: October 8, 2001 Received: October 11, 2001

## Dear Mr. Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 0 9 2001

Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K013372

Device Name: Clear Blue Easy Early Result Pregnancy Test

Indications For Use:

CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the The test has a sensitivity of 50mlU/ml hCG in urine, detection of pregnancy. detection of pregnancy. The cest nad a benefeling
and is indicated for use from four days before the expected missed period.

(Division Sign-Off) Division of Clinical Laborator

510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Optional Format 3-10-98)